EPIX's Vasovist not approved by FDA; layoffs imminent

By Angela McDaniels

Seattle, Nov. 23 - EPIX Pharmaceuticals Inc. said the U.S. Food and Drug Administration has asked the company to conduct additional studies before granting approval to blood-pool contrast agent Vasovist - studies that the company says will require a substantial period of time to complete.

"In light of today's news, we have decided that we will have to reduce substantially our research efforts and our employment levels, which we will do in the first quarter of next year," interim chief executive officer Michael J. Astrue said in a company press release.

"In addition to cutting our burn rate, these changes will allow us to focus our efforts on advancing our two lead products and our highest-priority research within our MRI franchise as we continue to seek to acquire a top-notch therapeutics company as early as possible next year."

The company received an approvable letter from the FDA. No safety or manufacturing issues were raised, but it indicated that at least one additional clinical trial and a re-read of images obtained in completed phase 3 trials will be necessary before the FDA can approve Vasovist.

EPIX is working with outside regulatory and clinical consultants and intends to talk with the FDA as it determines its next steps.

Vasovist was approved by the European Commission in October 2005 for marketing in the European Union, where it is indicated for visualization of abdominal or limb vessels in patients with vascular disease such as stenosis or aneurysms. A European launch is expected in the first quarter of 2006.

Vasovist was co-developed under a strategic partnership with Schering AG, a Berlin-based pharmaceutical company. Schering has global marketing rights for the product and said it will continue to support EPIX in its efforts to address the requests of the FDA.

EPIX is based in Cambridge, Mass., and develops pharmaceuticals for use in the diagnosis, treatment and monitoring of disease.

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